Add a Pregnancy Case

Vault Safety supports collecting information on pregnancy exposure to products and the birth outcome associated with each pregnancy.

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Tracking Pregnancy Exposure to Products

Add pregnancy cases to track pregnancy exposure to company products. Use the Pregnancy checkbox on a Case to identify that the patient is pregnant.

To track a pregnancy, open a Case for the pregnant patient. You can specify the following settings on a Case to track a pregnancy with no adverse event data:

  • Set event MedDRA to No adverse event (10067482)
  • Select the Pregnancy checkbox
  • Leave the Seriousness field Blank (Null)
  • To suppress submissions and exclude the Case from aggregate reports, select Suppress Submissions

In case of an adverse event in the mother, you can update that Case with the adverse event information.

Note You must track a case using the standard Case object type to be able to submit or distribute the report, if required.

Prerequisites

Ensure the Pregnancy and Parent-Child Case Data Collection feature is enabled in your vault.

Entering Birth Outcomes

If an adverse event occurs in the fetus or child, it must be captured and reported using a standard Case. See example scenarios below for more information.

Adverse Event in Child

Capture the adverse event in the child in a standard Case and link the Pregnancy Case as a Linked Case.

You must link the Child Case with a Parent Information Case in the Parent Information field for E2B transmissions. To do so, you must create a Parent Information record.

No Adverse Event in Child

When the child does not experience an adverse reaction, capture information about the child in a Child Information (child_information__v) type Case.

Create the Child Information Case from the Case for the tracked pregnancy to automatically link the two cases together.

E2B Transmission of Parent-Child Cases

For E2B compliant transmission of parent information for parent-child cases, in section D.10 for E2B (R3) or B.1.10 for E2B (R2), you must link the parent and child cases using the Parent Information field.

See E2B Generation Data Mapping for more information.

Example Pregnancy and Birth Outcome Scenarios

The following example scenarios outline how to capture pregnancy outcomes for the mother and child in an E2B-compliant way:

Note In the following example scenarios, it is assumed that you are already tracking the pregnancy in a standard Case with no adverse event.

Example 1: No Adverse Event in Mother or Child

  1. Update the Case for the tracked pregnancy to add information about the pregnancy outcome.
  2. From the Case for the tracked pregnancy, add a Child Information-type Case to enter the details of the child.
    This will automatically reference the tracked pregnancy case in the Parent Information field on the Child Information Case.
  3. Add a reference to the Child Information Case from the Linked Cases section on the Case tracking the pregnancy.
Example 1: No Adverse Event in Mother or Child
Example 1: No Adverse Event in Mother or Child

Example 2: Adverse Event in Mother, No Adverse Event in Child

  1. Update the Case for the tracked pregnancy to add information about the pregnancy outcome and the mother’s adverse event.
  2. From the Case for the tracked pregnancy, add a Child Information-type Case to enter the details of the child.
    This will automatically reference the tracked pregnancy case in the Parent Information field on the Child Information Case.
  3. Add a reference to the Child Information Case from the Linked Cases section on the Case tracking the pregnancy.
Example 2: Adverse Event in Mother, No Adverse Event in Child
Example 2: Adverse Event in Mother, No Adverse Event in Child

Example 3: Adverse Event in Child, No Adverse Event in Mother

  1. Update the Case for the tracked pregnancy to add information about the pregnancy outcome.
  2. Open a standard Case (not Child Information) to capture the adverse event in the child.
  3. From the Parent Information field on the Case for the child, add a Parent Information Case with details about the parent.

    Note You cannot change a regular Case object type to Parent Information type. You must open a separate Parent Information-type Case.

  4. Link the Case for the tracked pregnancy to the child Case using a Linked Case relationship.
Example 3: Adverse Event in Child, No Adverse Event in Mother
Example 3: Adverse Event in Child, No Adverse Event in Mother

Note The Case for the adverse event in the child must link to the parent case in the Parent Information field for E2B-compliant transmission of data in section D.10 for E2B (R3) or B.1.10 for E2B (R2).

Example 4: Adverse Event in Both Mother and Child

  1. Update the Case for the tracked pregnancy to add information about the pregnancy outcome and the mother’s adverse event.
  2. Open a standard Case (not Child Information) to capture the adverse event in the child.
  3. From the Parent Information field on the Case for the child, add a Parent Information Case with details about the parent.

    Note You cannot change a regular Case object type to Parent Information type. You must open a separate Parent Information-type Case.

  4. Link the Case for the tracked pregnancy to the child Case using a Linked Case relationship.
Example 4: Adverse Event in Both Mother and Child
Example 4: Adverse Event in Both Mother and Child

Note The Case for the adverse event in the child must link to the parent case in the Parent Information field for E2B-compliant transmission of data in section D.10 for E2B (R3) or B.1.10 for E2B (R2).

Add a Child Information Case

If the pregnancy outcome does not result in an adverse event in the fetus or infant, add a Child Information type Case.

You can add the Child Information Case directly from the pregnancy Parent Information Case from the Child Cases section. The parent and child cases are automatically linked with each other.

Enter Case Data: Child Information Section provides more information on creating and performing data entry on Child Information Cases.

Child Information Test Results

Once you save the Child Information Case, the system automatically creates Case Test Result records for you to capture the following information:

  • 1, 5, and 10 minute APGAR scores
  • Birth Outcome
  • Head Circumference

If the Parent Information Case references a MedDRA version, the above Test Results, except Birth Outcome, are auto-coded.


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